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Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822406
First Posted: January 14, 2009
Last Update Posted: January 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses of single individualized homeopathic medicines or placebo. After this closed initial phase, all patients were invited to participate in an long-term open-label controlled phase, in that they would receive homeopathic treatment for the maximum period of 36 months, and the results were compared with the improvement of initial phase. Signs and symptoms scores, rescue medication requirements and quality of life were assessed by questionnaires and personal clinical evaluation by a same independent researcher, before and after each phase. Primary and secondary clinical outcome were, respectively, specific and general allergic signs and symptoms scores. Total IgE titles were performed before and after each phase.

Condition Intervention Phase
Rhinitis Drug: homeopathic medicine Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • specific allergic signs and symptoms score [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • general allergic symptoms score [ Time Frame: 6 months ]

Enrollment: 41
Study Start Date: July 2002
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: 1
This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase)
Drug: homeopathic medicine
individualized homeopathic medicine
Placebo Comparator: 2
This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.
Drug: homeopathic medicine
individualized homeopathic medicine
Drug: placebo
placebo - 6 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate rhinitis
  • to assign written informed consent

Exclusion Criteria:

  • other chronic diseases
  • corticosteroid use
  • pregnancy
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcus Zulian Teixeira, Hospital das Clínicas da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00822406     History of Changes
Other Study ID Numbers: marcus@homeozulian.med.br
First Submitted: January 13, 2009
First Posted: January 14, 2009
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by University of Sao Paulo:
allergy
rhinitis
homeopathy
double-blind

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases